Indian Regulatory Requirements For Infant Food Formulae

The requirements of baby food vary across the world, but the desire to protect young children and promote healthy food is obvious. Many countries regulate this category, either as part of overall food regulation, or with baby food-specific rules and guidelines. The real objective is healthy food for infant, which makes it the primary focus of the regulation. This article will help you dive deep into the Indian regulations related to infant food products.

Regulations associated with Infant food in India

1. FOOD SAFETY AND STANDARDS (FOOD PRODUCTS STANDARDS AND FOOD ADDITIVES) REGULATIONS, 2011.

 

Infant Milk Substitutes

Infant Milk Food means the product made by spray drying of the milk of cow or buffalo or a mixture of both. The milk may be modified by the partial removal or substitution of different milk solids; carbohydrates, like sucrose, dextrose and dextrins or maltodextrin, maltose and lactose; salts such as phosphates and citrates; vitamins A, D, E, B, Vitamin C and other vitamins; and minerals like copper, iron, zinc and iodine. The source of mineral salts and vitamin compounds may be from sources mentioned in the regulations.

The product must be free of lumps and shall be uniform in appearance. It must be free from starch and added antioxidants. It must also be free from dirt, extraneous matter, preservatives and added colour and flavour and from anything which is harmful to human health. It shall not have rancid taste or musty odour. It shall not contain food additives. Various standards for infant milk food are mentioned in the regulations.

 

2. Letter Regarding Licensing of Infant Food Other than those Specified in Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011 and their compliance

The Food Safety and Standards Authority of India (FSSAI) on September 08, 2020 has released an advisory for strict compliance with provisions of Infant Milk Substitutes, Feeding Bottles and Infant Food (Regulation of Production, Supply and Distribution) Act, 1992 (The IMS Act).

Under Section 3 and 4 of the IMS Act, the advertising, promotions and incentivizing the use or sale of infant milk substitutes or feeding bottles or infant foods are strictly prohibited. Also, inducing healthcare workers for promoting use of infant milk substitutes, etc., including funding of seminars, meetings, conferences, educational courses, contests, fellowships, research work or sponsorship are also prohibited. Moreover, as per the Section 23 of the IMS Act, the offences are cognizable and the penalties may lead to imprisonment for a term which can extend to three years.

The FSSAI has directed all Food Business Operators (FBO) including all the E-commerce sites to strictly follow the provisions of the IMS Act, 1992 and desist from adopting surrogate promotions.

 

3. The Notification on Foods for Infant Nutrition

According to this notification the FSSAI has clearly mentioned that the infant milk substitutes, Feeding Bottles and Infant Foods (Regulation of Production, Supply and Distribution Act, 1992) stipulates that any such infant food products which do not have standards under FSS Act, 2006 are need to seek prior approval of the Central Government of India.

Moreover, the FSS (Prohibition and Restriction on Sales) Regulations, 2011 also clarifies that ’No person shall manufacture, sell, store or exhibit for sale, an infant milk food, infant formula and milk cereal-based weaning food, processed cereal-based weaning food and follow up formula except under Bureau of Indian Standards Certification Mark.’

Testing of these infant food products is similar to that of any other food product. During testing, microbial and chemical contamination must be considered. The labelling of nutrients and their contents must be checked to ensure they are in compliance to the regulations. Labels must be checked to make sure that they are according to the requirements of the country. Choking is one of the common causes of injury and death in young children because their small airways are easily obstructed. Processing requirements must take extra precaution to consider foreign substances and those materials that can cause choking, as young children are more susceptible. Recalls on foreign materials in baby foods frequently occur, mainly due to glass fragments. For the complete range of food regulatory services and support, visit our www.cliniexperts.com

 

References:

1. FOOD SAFETY AND STANDARDS (FOOD PRODUCTS STANDARDS AND FOOD ADDITIVES) REGULATIONS, 2011.Available at: Compendium_Food_Additives_Regulations_08_09_2020-compressed.pdf (fssai.gov.in).Accessed on 10^th April, 2021.
2. 5f588003d3788Direction_Compliance_Infant_Food_09_09_2020.pdf. Available at:
   https://www.fssai.gov.in/upload/advisories/2020/09/5f588003d3788Direction_Compliance_Infant_Food_09_09_2020.pdf . Accessed on 10^th April, 2021.
3. Letter Regarding Licensing of Infant Food Other than those Specified in Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011 and their compliance Available at: https://www.fssai.gov.in/upload/advisories/2020/09/5f644d90ca87eLetter_License_Infant_Food_18_09_2020.pdf . 10th April, 2021.